FWP 1 a15-21037_5fwp.htm FWP

Issuer Free Writing Prospectus Dated November 2, 2015

Filed Pursuant to Rule 433

Registration No. 333-196374

 

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The Oncology Diagnostics Partner From Bench to Bedside Investor Presentation NASDAQ: CGIX November 2015

 

 

 


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This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates“, “proformas”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Cancer Genetics, Inc. Forms 10-K for the year ended December 31, 2014 and 10-Q for the quarter ended June 30, 2015 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements. This presentation also contains “forward-looking statements” and Proforma information regarding the Company’s acquisition of Response Genetics, Inc. (“Response Genetics”) and the anticipated benefits from the acquisition. The Company cautions that these statements are subject to certain risks, including, but not limited to, the effects of the bankruptcy proceeding on the business of Response Genetics; risks that the Company will not realize the anticipated benefits of such transaction; risks that the Proforma financial information included in this presentation may not necessarily reflect the Company’s operating results and financial condition following the acquisition. Forward-Looking Statement

 


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This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing in our company. We have filed a Registration Statement on Form S-3 with the Securities and Exchange Commission including a base prospectus, and a preliminary prospectus supplement, dated October 30,2015 (collectively the “Prospectus”) with respect to the offering of shares of the Company’s common stock to which this communication relates. Before you invest, you should read the Prospectus (including the risk factors describes therein) and, when available, the final prospectus supplement relating to the Offering, and the other documents filed with the SEC and incorporated by reference into the Prospectus for more complete information about us and the offering. You may get these documents, including the preliminary prospectus dated October 30, 2015, for free by visiting EDGAR on the SEC website at http://sec.gov. The preliminary prospectus, dated October 30, 2015, is available on the SEC website at http://sec.gov. Alternatively, we or any underwriter participating in the offering will arrange to send you the prospectus if you contact Joseph Gunnar & Co, LLC, Prospectus Department, 30 Broad Street, 11th Fl, New York, NY 10004, telephone 212-440-9600, email: prospectus@jgunnar.com. FREE WRITING PROSPECTUS STATEMENT

 


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CGIX - Offering Summary Issuer Cancer Genetics, Inc. Listing NASDAQ Capital Market: CGIX Use of Proceeds General corporate purposes including integration of recent acquisition; sales & marketing to support new product launches; and to fund our contributions to OncoSpire, our JV with Mayo Joint Book-Runners Joseph Gunnar & Co. and Feltl and Company Co-Manager Axiom Capital Management, Inc.

 


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Large, Global Market Opportunities $458B GLOBAL ONCOLOGY SPEND BY 2030 Global Footprint Created by Highly Strategic M&A 3 TRANSFORMATIVE ACQUISITIONS IN 2014 & 2015 Strong & Growing Partnerships with Leading BioPharma CONTRACTS WITH 7 of 10 TOP BIOPHARMA INCREASING REVENUE & PIPELINE(1) WITH BIOPHARMA CUSTOMERS Innovation Engine & Expertise Driven By Key Collaborations 17 RESEARCH COLLABORATIONS WITH LEADING INSTITUTIONS Unique, Proprietary Portfolio of Genomic Tests & Panels 10 COMMERCIALLY LAUNCHED TESTS 30 US PATENTS and 84 Foreign Patents Diversified & High Growth Revenue Streams REVENUE GROWTH: 36% 4-YEAR CAGR / 55% AAGR World-Class Management Team 100+ CUMULATIVE YEARS OF EXPERIENCE Investor highlights: Cancer genetics is uniquely positioned to address the trends in oncology from bench to bedside 1. In signed contracts & potential future revenue

 


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Clinical Trials Research Patient Care Our Mission is To be The Oncology Diagnostics Partner of Choice From Bench to Bedside PARTNERING WITH LEADING RESEARCH INSTITUTIONS TO DRIVE INNOVATION AND DEVELOP NEW INSIGHTS DELIVERING CRITICAL GENOMIC INSIGHTS TO MEDICAL PROFESSIONALS TO PERSONALIZE TREATMENT & IMPROVE OUTCOMES PROVIDING UNPARALLELED EXPERTISE TO BIOPHARMA COMPANIES FOR IMPROVED THERAPEUTIC DEVELOPMENT

 


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Uniquely Positioned to Address Macro-Trends in oncology Increasing Global Need for Improved Diagnosis and Management Global Footprint DEEP, DISEASE-FOCUSED GENOMIC KNOWLEDGE and INSIGHTS PROVEN DISEASE specific & experience CAPABILITIES Growing Awareness & Adoption of Genomic Testing by Clinicians and Patients Highly Skilled Sales Force Continuous Need to Incorporate New Technologies & Improved Analytic Capabilities Comprehensive & Platform Agnostic Majority of Oncology Clinical Trials Now Incorporate genomic Biomarkers Rx, Dx, & CDX Expertise FOCUSED ON CREATING DURABLE SHAREHOLDER VALUE

 


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GLOBAL ONCOLOGY MARKET FORECAST & POTENTIAL GLOBAL SPENDING ($ in Billions) US EU5 JAPAN PHARMERGING ROW Source: IMS Health MIDAS, Dec. 2014; IMS Health Market Prognosis, March 2015. Oncology includes therapeutic treatments as well as supportive care, radiotherapy and immunotherapies $100B ~$135B CAGR 2014–2018: 6–8% POTENTIAL MARKET Community Hospitals Regional Cancer Centers 4,000+ u.S. Hospitals 3,000+ U.s. clinical Trials for all cancer Types Pharmaceutical & Biotechnology Companies 200+ Research Centers In the U.S. Universities & Research Centers 85% Oncology patients Treated in Community Setting $42B ~$57B 2014 2018

 


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Key M&A Criteria Targeted Acquisitions 90,000 sq. ft. Global Footprint Response Genetics, Inc. (October 2015) Leading solid tumor testing franchise with content in lung, colorectal, skin and brain cancers as well as FDA-cleared Tissue of Origin Test™ Strong commercial presence in the Western & Southeastern US with 3,000+ customers Established community oncologists & pathologists sales channel United States BioServe Biotechnologies, India (August 2014) First company to provide DNA synthesis, DNA sequencing & related services in India Customers include leading cancer research institutes (ICMR, CSIR) as well as major pharmaceutical and biotechnology companies Gentris, Corp. (July 2014) Leading global provider of biopharma, discovery, pharmacogenomics, next-generation sequencing, genotyping, and biorepository services US FDA-compliant lab in Zhanjiang Hi-Tech Park, Shanghai, China Response Genetics Los Angeles, CA Gentris Rtp, nc Headquarters Rutherford, nj ACTIVE and Successful M&A Strategy focused on Growth, Capabilities, and Global Footprint Access to Differentiated Oncology Testing Capabilities & Content Ability to Expand Geographic Footprint Into Key, High Growth Markets Opportunity to Strengthen & Diversify Customer Base Across Research, BioPharma & Clinical End Markets Ability to Realize Commercial & Operational Synergies Shared Cultural Values Based on Innovation & Teamwork Bioserve hyderabad India Gentris shanghai China

 


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Combined portfolio covers 8 of the 10 most prevalent cancers Geographic reach Highly experienced sales force focused on the community oncologist & pathologist markets Commercial presence $2-3 MN BioPhaRMA(2) TISSUE Of Origin® is Only FDA-Cleared & Medicare-reimbursed test of its type Extensive & HIGHLY Complementary Solid tumor testing portfolio Strong Commercial presence in the Western & Southeastern US $8-9 MN clinical Expected over the next 12 months Includes ALCHEMIST, a group of clinical trials for patients with certain types of early-stage non-small cell lung cancer (NSCLC) that have been treated surgically. Acquired October 2015 RESPONSE genetics, inc. Acquisition highlights(3) Estimated revenue Contribution(1) $10-12 MN Transaction HIGHLIGHTS Global footprint Includes $7MN IN CASH AND 788,584 SHARES OF cgi COMMON STOCK Adds 27,000 sq ft for a total of 90,000 sq ft of state-of-the-art lab space

 


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>$30+M Anticipated Future Revenues From Biopharma Customers Biopharma Revenue and future Growth(1) Approximate expected future revenues under signed contracts with biotechnology & pharma customers for testing & services to support currently planned clinical trials ($ in millions) Strong & growing Relationships with Leading Biopharma Companies CGI has Contracts WITH Top biopharma Companies 7 of 10 Number of clinical trials CGI is actively supporting with its testing, genomic services, & Biomarker capabilities 70+ $0.6M $2.7M $5.6M $8.6M 2012 2013 2014 9 mos 2015

 


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Global CRO industry leader specializing in Phase I through Phase IV clinical trial testing $1.5B in net annual revenue & approximately 11,000 employees ICON has conducted over 950 oncology studies, assessing over 148,000 patients at nearly 27,500 sites worldwide over the past 5 years ICON has expertise in tumor imaging, laboratory (including PK/PD and Biomarkers) IVRS, central data management, electronic data capture and regulatory oncology issues ICON has significant presence in oncology Combined capabilities provide significant oncology insights across ICON’s 950+ Phase I - Phase IV clinical trial studies Provide clients access to combined expertise in oncology-focused genomic testing, disease-specific proprietary genomic panels, and world-class bioinformatics. Tests and services offered by Cancer Genetics (CGI) through ICON will be branded as “POWERED BY CGI” Cross training of global sales forces & scientific affairs teams scheduled during Q3 & Q4 of 2015 CGI has already realized cross- and up-selling wins with joint selling efforts Future potential opportunities to partner with other service and technology providers to create enhanced capabilities for BioPharma customers ICON Partnership & Strategic Alliance Enabling Unparalleled Comprehensive Oncology Laboratory Testing and Solutions to the BioPharma Industry icon Cgi & icon partnership

 


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Collaborations with world-renowned Cancer Research Institutions Disease Target Collaboration Highlights Beth Israel Deaconess Medical Ctr DLBCL (Diffuse Large B-Cell Lymphoma) Biomarker-based outcome prediction using Focus::Lymphoma™ and MatBA®-DLBCL Cleveland Clinic Kidney Cancer Genomic marker validation Columbia University AML, MDS, and Myeloid Cancers (Acute Myeloid Leukemia, Myelodysplastic Syndromes) NGS panel development Groupe Hospitalier Pitié Salpétriêre, Paris Kidney Cancer Analysis of biomarker variability by array-CGH & NGS Huntsman Cancer Institute, University of Utah Kidney Cancer Evaluation of biomarkers of response using Focus::Renal™ & array-CGH Kamineni Hospital, India Cervical Cancer FHACT® evaluation Keck Medicine of USC DLBCL and FL (Follicular Lymphoma) Biomarker investigation Memorial Sloan-Kettering Cancer Ctr Kidney Cancer Array-CGH & NGS core needle biopsy analyses & biomarkers assoc. w/metastasis Moffitt Cancer Center CINV and PGx Prediction of side effects associated with chemotherapy (CINV) National Cancer Institute Cervical Cancer FHACT® development & cervical cancer screening trials North Shore LIJ Health System CLL/SLL CLL/SLL validation & BTK inhibitor resistance University of Alabama Central Nervous System Lymphoma Biomarker investigation University of Iowa Cancer Center DLBCL, Lymphoma MatBA®-DLBCL and Focus::Lymphoma™ validation Westchester Medical Center Central Nervous System Lymphoma Genomic biomarker identification using UroGenRA®

 


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OncoSpire Genomics Joint Venture between Cancer Genetics & Mayo Clinic Joint venture based in Rochester, MN Goal: to develop tests that will become the gold standard in diagnosing and managing patients with selected disease targets Diseases with known clinical dilemmas were selected and informed by clinicians in the Mayo Clinic network OncoSpire has the rights to druggable targets that are discovered Project Pipeline(1): ~115,000 New Cases Per Year global Multiple Myeloma Lung Cancer Follicular Lymphoma ~1.8M New Cases Per Year global Research & Discovery Clinical Development Commercial development Launch & Market Entry Q4 2015 Expected Launch ~130,000 New Cases Per Year global Pipeline of projects may change based on business or scientific rationale

 


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NGS Panel Highlights Multiple Myeloma: Setting the New Standard with a Focused NGS Panel Highly targeted 88 gene panel design Initial design can work on on both major NGS platforms OncoSpire will license to Mayo and CGI for clinical offering 4 papers in the publication process, including at ASH Multiple international early-access collaborations being established A comprehensive NGS-based panel will be developed to 1 Provide greater certainty & reduce complexity of diagnosis Replaces existing paradigm of testing using multiple clinical tests including: cytogenetics, FISH, single biomarkers & gene expression profiling 2 Establish earlier, more accurate, & cost-effective prediction of MM transformation Identifies mutations that predict change from MGUS to MM Provides information on clonal evolution Identifying MGUS (precursor to MM) patients that need earlier follow-up and earlier treatment Determining best treatments for malignancies based on potential biomarker profile of patient Increasing consistency and accuracy across clinical techniques used to gauge patient prognosis and therapeutic response MULTIPLE MYELOMA BASICS 1 National Cancer Institute – SEER Stat Fact Sheet (seer.cancer.gov) 2 Value Based Cancer Care (Article 1874 05/20/2015 – Caroline Helwick) MAJOR CLINICAL & UNMET NEEDS 3 Identify targets for therapeutic selection & identify new druggable targets Identifies mutations that are aligned with new classes of therapies Provides data on cerebelon and other key biomarkers for clinical trials Total Cases Worldwide ~230,000 & In USA ~78,0001 5 Year Survival Only ~33% to 43%1 Lifetime therapy costs for patients in USA range from ~$120,000 to $240,000 without costs for managing side effects2 Over 250 therapeutic agents for MM in the pipeline2

 


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Tissue of origin® [FDA-Cleared] UroGenRA®-Kidney FHACT® Cervical Focus::Cancer HOTSPOT™ Unique, Proprietary Portfolio of Genomic Tests & Panels Research & Discovery Clinical Development Commercial development Focus::Myeloid™ Focus::Lymphoid™ Focus::CLL™ MatBA® For B-cell Cancers Test In Market 4 Tests In Market Late 2015 Multiple Myeloma Follicular Lymphoma Lung Cancer TBD Late 2015 Early 2016 Test In Market Focus::Renal™ Test In Market Test In Market Test In Market Early 2016 Late 2015 Hereditary Panel Comprehensive Pharmacogenomics (PGx) Panel Early 2016 Blood cancers ONCOSPIRE GENOMICS(2) Solid Tumors Hereditary Provide comprehensive and technology agnostic methodologies Drive novel discovery and development through partnerships with key thought leaders Target unmet and critical disease states Meaningfully impact and improve clinical trials and patient care Market Entry Pipeline of projects may change based on business or scientific rationale Joint Venture with the Mayo Clinic Guiding Principals for Portfolio Development(1) Test In market

 


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® Solution MatBA®-CLL/SLL stratifies patients into 3 distinct risk groups using 20 biomarkers: 38% of cases are favorable falling under "watch & wait" approach 8% of Unfavorable cases missed by FISH are detected by MatBA®-CLL/SLL 23% 39% 38% Favorable Intermediate Unfavorable Problem Standard FISH testing for CLL stratifies patients into 2 risk groups using 4 biomarkers Favorable/Intermediate Unfavorable 85% 15% Driving Improved insight and Management FOR Chronic Lymphocytic Leukemia (CLL) Used in several major global clinical trials Routinely used in clinical care for guiding patient management

 


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GUIDING Management and Appropriate Treatment Selection FOR Kidney cancer Patients with renal masses often undergo unnecessary nephrectomy for accurate diagnosis & experience delay in treatment Over 15% of needle biopsies of renal masses are rendered non-diagnostic Problem UroGenRA®-Kidney assesses 16 genomic biomarkers in a single assay Provides accurate diagnosis guiding appropriate clinical management and treatment strategies (benign vs. malignant; malignant subtype) Reduction in number of highly invasive procedures & time to treatment initiation Solution Proprietary Diagnostic Algorithm >400 Patient data set Used for validation Of rcc subtyping in-silico: SNP >100 Patient samples with Malignant & Benign Renal Neoplasms in-house: aCGH & FISH Retrospective in-house FFPE validation (n>190) 100% Diagnostic Yield 97% Diagnostic Sensitivity to distinguish benign/malignant 93% Sensitivity to distinguish malignant RCC subtypes Prospective percutaneous Core needle biopsy (expect 50) Demonstrated ability to diagnose pathologically “unclassifiable” Biopsies prior to surgical intervention ®

 


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FHACT® Fits Directly into Today’s Cervical Screening Workflow 55.0M Pap Smears 3.5M Unclear/ Abnormal 2.0M Procedures 13K Cases of cancer Today, all HPV+ women with abnormal Pap results are referred for colposcopy Several cervical cancer tests are available but the need for less invasive and better informed treatment exists Problem FHACT® helps triage before colposcopy Non-invasive test performed on remnant liquid cytology – no resampling is necessary which means no additional doctor visit Fewer women referred for colposcopy reducing healthcare costs & patient anxiety Measured 94% Sensitivity & Specificity in 199 patient study presented at HPV 2015 Solution RECENT UPDATE: HPV 2015 Results from 2 independent cervical cancer-related studies during the 30th International Papillomavirus Conference & Clinical & Public Health Workshops “Chromosomal Gains Measured by Fluorescence in situ Hybridization in Cytology Samples” was conducted in collaboration with the National Cancer Institute (NCI) “Evaluation of Gain of Four Chromosomal Loci by Fluorescence in-situ Hybridization on Pap Smears of Women in India” in collab with Kamineni Hospital, Hyderabad Today, all these women are referred for colposcopy PROGRESS to a higher grade and increased risk for cancer within 10-30 years of the infection REGRESS within 2 years of the infection Not referred for colposcopy FHACT® Results: Normal Referred for colposcopy FHACT® Results: Abnormal ~90% ~10% HPV+ women with abnormal or unclear liquid-based cytology

 


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Tissue of Origin® identifies challenging tumors, including metastatic, poorly differentiated & undifferentiated cancers CHANGE IN DIAGNOSIS Working Diagnosis Prior to TOO® Results Working Diagnosis After TOO® Results N = 107 34% of the time Confirm Working diagnosis Identifies a New site(1) 50% of the time CHANGE IN Therapy Chemotherapy Radiation Additional Studies Hospice Surgery Changes in Treatment After TOO® Results Clinical Management After TOO® Results Leads to change In treatment(1) 65% of the time The Tissue of Origin® (TOO®) reports the most likely tissue of origin of 58 morphologic subtypes from 15 of the most common tumor types: Thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate 2000 genes, covering 15 tumors types and 90% of all solid tumors(2) FDA-cleared with extensive analytical and clinical validation Medicare-reimbursed average collections at ~$2,700 Statistically significant improvement in accuracy over other methods, including IHC(3) (1) Oncotarget 2012 Jun;3(6):620-8. (2) J Molec Diag 13 2011;13:48-56. (3) J Surg Pathol 2013;37:1067. Changed 65% No Change 35%

 


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TARGETED CLINICAL TRIALS DRIVE REVENUE TODAY and MARKETSHARE IN THE FUTURE REVENUE TODAY FOR BIOPHARMA SERVICES FUTURE REVENUE IN CLINICAL CARE TODAY future >10 MIGHT TRANSFORM CANCER CARE BASED ON CGI’s estimate of A 15% APPROVAL RATE 2-3 Potential COMPANION DX To Accelerate clinical Growth & profitability CLINICAL TRIALS WITH CGI 74

 


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2 US Patents EU India Canada Mature B-Cell Neoplasms 3 US Patents Tissue of Origin 2 US Patents EU Renal Cortical Neoplasms 13 US Patents PCT AU CA China Japan Gene Expression 2 US Patents Canada Chromosomal Analysis Using FISH 2 US Applications Filed PCT Gynecological Cancers & Precancers 3 US Patents PCT HPV-Associated Cancers Disease-FOCUSED Patent Portfolio: 84 Global patents Select significant Patents Include: Application Submitted Term Through 2022 Term Through 2023 Term Through 2027 Term Through 2029 Term Through 2030 Term Through 2031

 


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Diversified and Growing Revenue Base 55% 43% 2% Full Year 2014 $10.2M 69% 26% 5% 9 mos 2015* $12.6M Entered into partnership with ICON to offer access to ICON Laboratory Services combined with Cancer Genetics Focus::CLL™ chosen for global clinical trial by leading biotechnology company Biopharma global biotech and pharmaceutical companies Launched new NGS panels, including Focus::Myeloid™ Acquired Response Genetics – testing capabilities now cover 8 of the top 10 cancers Clinical cancer centers, hospitals, regional labs, and clinicians New research studies with leading cancer centers and academic institutions Selected by regenerative medicine company, ReproCELL, Inc., to provide (NGS) services Discovery preclinical research groups at academic, Government & commercial organizations Nine months 2015, Medicare represented 8% and other insurers represented 7% of consolidated quarterly revenue. * 9 mos 2015 based on preliminary results, subject to finalization.

 


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Strong Record of Continuous Growth Revenue growth by Year / Category ($ in millions) BIOPHARMA CLINICAL DISCOVERY OTHER 2013-2014 Revenue highlights TOTAL REVENUE GROWTH OF 54% $6.6M TO $10.2M BIOPHARMA REVENUE GROWTH OF 112% $2.7M TO $5.6M CLINICAL REVENUE GROWTH 0F 21% $3.7M TO $4.4M $4.3 $6.6 $10.2 $12.6 * 9 mos 2015 based on preliminary results, subject to finalization. $0.6 $2.7 $5.6 $8.6 $3.2 $3.7 $4.4 $3.3 $0.4 $0.7 $0.6 $0.7 2012 2013 2014 9 mos 2015*

 


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Strong Record of Continuous Growth first 9 months 9 mos Revenue 2014-2015 / Category ($ in millions) BIOPHARMA CLINICAL DISCOVERY 9 mos Revenue 2014-2015 highlights TOTAL REVENUE GROWTH OF 104% $6.2M TO $12.6M BIOPHARMA REVENUE GROWTH OF 207% $2.8M TO $8.6M $6.2 $12.6 * 9 mos 2015 based on preliminary results, subject to finalization. $2.8 $8.6 $3.3 $3.3 0.1 0.7 9 mos 2014 9 mos 2015*

 


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PRO FORMA REVENUES * The pro forma revenue numbers above may not be indicative of the consolidated results in the future. Acquisition completed October 2015. 2013 2014 Thru 9/30/2015* CANCER GENETICS RESPONSE GENETICS PRO FORMA ($ in millions) +$32M PRO FORMA ANNUAL REVENUE RUN RATE* ~$4.5M ADDITIONAL POTENTIAL REVENUE FROM BIOPHARMA TRIALS CANCER GENETICS’ AND RESPONSE GENETICS’ PRO FORMA REVENUE highlights * 9/30/2015 based on preliminary results, subject to finalization.

 


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Cancer genetics Standalone summary Statement of Operations Summarized income statements (dollars in thousands) Summarized Balance sheet (dollars in thousands) 2014 9 mos 2015 9 mos* Revenue $6,164 $12,556 Gross Profit 805 3,213 Gross Margin (%) 13% 26% Research & Development 3,093 4,335 Sales & Marketing 2,738 3,543 General & Administrative 8,231 9,536 Operating Profit (Loss) ($13,257) ($14,201) Net Income (Loss) ($11,470) ($14,470) Non Cash adjustments $2,509 $2,859 Net Income (Loss) excluding Non Cash Items + ($8,961) ($11,611) Actual 09/30/15 All Cash $19,918 Stockholders’ Equity $22,318 +This is non GAAP measure. Adjustments are depreciation ($508 and $997), equity compensation ($2,130 and $2,178) and other ($129 and $316) respectively * 9 mos 2015 based on preliminary results, subject to finalization.

 


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CGI Payment history – 9 months 2015 (clinical revenues only) 33% 29% Regional And National Payers Medicare Commercial Payers 38% Direct bill Covered Lives Represented by agreements with national integrated networks America’s Choice Provider Blue Cross Blue Shield of Alabama Blue Cross Blue Shield of Illinois Blue Cross Blue Shield of Michigan Blue Cross Blue Shield of Minnesota Blue Cross Blue Shield of North Carolina Blue Shield of CA Care First of Maryland More Than +45M Credentialing Organizations (NCQA, CAQH) Encore Health Network Harvard Pilgrim Health Plan MultiPlan TRICARE military plan Tufts Health Plan of Massachusetts WellMark, Inc. Nine months 2015, Medicare represented 8% and other insurers represented 7% of consolidated quarterly revenue. Historical clinical reimbursement Mix & Payer coverage

 


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Capital Structure Fully-Dilutive Shares Outstanding as of 10/28/2015 % . Company Stock, Issued & Outstanding 10,651,924 77.3% Equity Awards – Stock Options1 2,004,853 14.6% Warrants2 1,116,940 8.1% Fully-Diluted Shares Outstanding 13,773,717 100% 1 Weighted-average exercise price of $10.52. 2 Weighted-average exercise price of $13.53.

 


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Upcoming Presentations AMP Annual Meeting, November 5-7, 2015 A Multi-Platform Approach for the Detection of Mutations in 54 Genes with Relevance to Myeloid Neoplasms in a Clinical Laboratory Setting Systematic Analysis of Common Copy Number Variations in Diffuse Large B-cell Lymphomas International Kidney Cancer Symposium, November 6-7, 2015 Molecular Predictors of Response and Survival Outcomes in Patients with Metastatic Clear Cell Renal Cell Carcinoma (mccRCC) Treated with Vascular Endothelial ASH Annual Meeting, December 5-9, 2015 A 220-Gene Targeted Next-Generation Sequencing Panel for the Detection of Variants in DLBCL, FL, and MCL: Application to a Cohort of 85 FFPE DLBCL Biopsies Systematic Analysis of Cell of Origin, Sequencing and Genomic Imbalances Identifies a Distinct Subset of Rituximab Treated Diffuse Large B-Cell Lymphoma with an Inferior Survival GU-ASCO, January 7-9, 2016 Metastasis-Associated Mutations in Clear Cell Renal Cell Carcinoma Clinical Utility of a Custom Next-Generation Sequencing Panel in the Diagnosis of Needle Biopsies from Renal Masses

 


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SIGNIFICANT ONGOING Milestones Expected in Coming Quarters Major partnerships and contracts with leading oncology therapeutic companies Contracts in immuno-oncology programs with Top 10 pharma and biotechs Announcements of milestones from ICON program and strategic alliance Leveraging capabilities from acquisition to grow CGI Biopharma capabilities and contracts FHACT® - Additional highlights from NCI and India studies Adoption by a major hospital for triaging of HPV-positive women Launching of a FHACT® advisory board and health economic study to drive adoption 5 major publications in next 90 days at AMP, GU-ASCO, ASH and Kidney Cancer Conf. Increasing covered lives & market access through additional payer contracts Initiation of studies with regional cancer consortiums and ACOs Agreements for FHACT®; TOO® & Focus::NGS™ panels Launching multi-marker NGS panel for lymphoid malignancies FOCUS::Lymphoid Launch and market entry of NGS panel for renal cancers FOCUS::Renal™ Launch and market entry of hereditary cancer NGS panel focused on women’s health Multiple Myeloma NGS panel launch (via OncoSpire) Biopharma Partnerships & Contracts Additional Studies & Data For Test Support Payer Contracts & Reimbursement NGS Panels Launched

 


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Experienced leadership team Panna Sharma Chief Executive Officer & President, Board Member Edward J. Sitar, CPA Chief Financial Officer & Treasurer Rita Shaknovich, MD, PhD Group Medical Director & VP, Hematopathology Services Mandar Kulkarni, PhD Chief Technology Officer, India Jane Houldsworth, PhD VP, Research & Development Greg Ash VP, Clinical Market Development Randy Goodman, PhD Director, Reimbursement & Managed Care Scott Clark, PhD VP, BioPharma Scientific Affairs & Global QA Rob Fannon, MBA, MPH VP, Biopharma Operations Kamala K Maddali DVM, PhD VP, Biopharma Collaborations and Companion Diagnostics 10+ years operations, client mgmt, and molecular test & panel dev. 5 years in life science and pharmaceutical equity research Roche Molecular Diagnostics, BioServe Biotechnologies, Ltd. 15+ years as advisor to global life science & healthcare companies TSG Partners, iXL Enterprises, Interactive Solutions, Putnam Investment 30+ yrs in finance & deal making in the healthcare industry Healthagen (Aetna), Cadent Holding, MIM Corp, Coopers & Lybrand (PWC) 16+ years at pharma and clinical research companies CAP Biorepository Director and oversees China operations Gentris Corporation 15+ years in both clinical and research capacities Weill Cornell Medial College, Mount Sinai, Columbia Presbyterian Hosp. 10+ years in global P&L scientific and commercial management arena Quest Diagnostics, Quintiles and Merck Schering Plough 25+ years in translational oncology research MSKCC, CALTECH 20+ years in health economics & healthcare policy Healthcare Mgmt Solutions, Scientia Advisors, ImpediMed 5+ years in both clinical and genomic development Sandor Lifesciences, M/Z Diagnostics 16+ years in the healthcare sector Go Path Laboratories, Response Genetics

 


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BOARD OF DIRECTORS Panna Sharma CEO & president of Cancer Genetics General Manager of OncoSpire Genomics Previously managing partner/founder of TSG Partners 70+ buy & sell-side transactions (healthcare companies) Raju S.K. Chaganti, PhD Founded CGI & served as Chairman until 2014 Internat’ly recognized leader in molecular genetics Co-discovered lymphoma & kidney cancer patents Incumbent of the William Snee E. Chair at MSKCC John Pappajohn Non-Executive Chairman Involved in 100+ start-up companies Served as director of 40+ public companies Currently on boards of: American CareSource Holdings; ConMed Healthcare Mgmt; CNS Response Howard McLeod, PharmD g Personalized Medicine Medical Director at Moffitt Founding Director of the Univ. of NC Institute for Pharmacogenomics (PGx) & Individualized Therapy 475+ peer-reviewed papers (PGx, applied therapeutics) Michael J. Welsh, MD c, g Investigator at the Howard Hughes Medical Inst. Roy J. Carver Biomed Research Chair in Internal Medicine & Molecular Physiology & Biophysics Director of Univ. of Iowa Inst. for Biomed Discovery Geoffrey Harris, CFA a 30+ years experience as healthcare analyst & portfolio manager for biotech/life sci companies Portfolio manager/managing partner at c7 Advisors Previously: Cantor Fitzgerald; Gleacher & Company Ted Cannon a,c Founder & President of the Clinical Research Center of Cape Cod Previously at Franey Medical Labs; Pharmacia Diagnostics; Alletess Franklyn Prendergast, MD, PhD a, c, g Director of Mayo Clinic for Individualized Medicine (Retired) Currently on boards of: Translational Genomics Research Inst.; Infectious Disease Research Inst.; DemeRx, Inc.; Ativa; Eli Lilly & Co. a: Audit Committee c: Compensation Committee g: Governance and Nominating Committee

 


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Large, Global Market Opportunities $458B GLOBAL ONCOLOGY SPEND BY 2030 Global Footprint Created by Highly Strategic M&A 3 TRANSFORMATIVE ACQUISITIONS IN 2014 & 2015 Strong & Growing Partnerships with Leading BioPharma CONTRACTS WITH 7 of 10 TOP BIOPHARMA INCREASING REVENUE & PIPELINE(1) WITH BIOPHARMA CUSTOMERS Innovation Engine & Expertise Driven By Key Collaborations 17 RESEARCH COLLABORATIONS WITH LEADING INSTITUTIONS Unique, Proprietary Portfolio of Genomic Tests & Panels 10 COMMERCIALLY LAUNCHED TESTS 30 US PATENTS and 84 Foreign Patents Diversified & High Growth Revenue Streams REVENUE GROWTH: 36% 4-YEAR CAGR / 55% AAGR World-Class Management Team 100+ CUMULATIVE YEARS OF EXPERIENCE Investor highlights: Cancer genetics is uniquely positioned to address the trends in oncology from bench to bedside 1. In signed contracts & potential future revenue

 


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The Oncology Diagnostics Partner From Bench to Bedside CGI Headquarters 201 Route 17 North Rutherford, NJ 07070 Phone: +1 201-528-9200 Fax: +1 201-528-9235 RUTHERFORD, NJ Research Triangle Park 133 Southcenter Court Morrisville, NC 27569 Phone: +1 919-465-0100 Fax: +1 919-465-0554 RALEIGH, NC LOS ANGELES, CA 1640 Marengo Street Seventh Floor Los Angeles, CA 90033 Phone: +1 323-224-3900 Fax: +1 323-224-3096 #3-1-135/1A CNR Complex Mallapur Main Road, R.R. Dst. Hyderabad – 500 076, Telangana Toll-free: +91 040-2717-8178 Fax: +91 040-2717-8176 HYDERABAD, INDIA 781 Cai Lun Road, Room 803 Shanghai 201203 P.R. China Toll-free: +91 040-2717-8178 Fax: +91 040-2717-8176 SHANGHAI, CHINA www.cgix.com www.cancergenetics.com

 


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Tissue of origin® competitor comparison CRITERIA Tissue of Origin® CancerTYPE ID™ Cancer Origin Test™ EXTERNAL REVIEW FDA CLEARED Yes No No MEDICARE COVERED Yes Yes Yes PEER-REVIEWED PUBLICATIONS 23 21 6 VALIDATION STUDY NUMBER OF GENES MEASURED 2,000 92 64 Accuracy (measured as Positive Percent Agreement; akin to sensitivity) 89%(1) 85%(2) 74% or 85%(3) (algorithm dependent) Certainty for rule-outs (measured as Negative Percent Agreement; akin to specificity) 99% 99% 99% (1 algorithm only; Rule-outs not reported) LOWEST published accuracy for an individual tissue 72% (Gastric) 48% (Endometrium) Not Published Number of individual tissues with at least 25 published validation specimens (at least 25 specimens recommended for statistically relevant calculations) 100% of all reported (17 tissue types) 37% of all reported (28 tissue types) 2% of all reported (1 tissue type) (1) Pillai et al. Microarray-based gene expression assay for identification of primary site using FFPE tissue. J Molec Diag 13 2011;13:48-56. Jan. 2011. (2) Kerr et al. Multisite validation study to determine performance characteristics of a 92-gene molecular classifier. Clinical Cancer Research, Published online May 30, 2012. Recalculated including unclassifiable cases. (3) Meiri et al. A second generation microRNA-based assay for diagnosing tumor tissue of origin. Oncologist 2012 May 22.